Home NDC 0031-8760 Childrens Robitussin Honey Cough and Chest Congestion DM
Product NDC 0031-8760
11-digit product format 000318760
Labeler code 0031
Product ID 0031-8760_80b851fe-4f4e-460c-8a7b-dbe2e8fbe072
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan HBr, guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-25
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 100 mg/10mL; mg/10mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Robitussin Honey Cough and Chest Congestion DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL GUAIFENESIN 100 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790650 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0031-8760-12 Childrens Robitussin Honey Cough and Chest Congestion DM 118 mL in 1 BOTTLE SOLUTION 118 8 0031-8760-12 Childrens Robitussin Honey Cough and Chest Congestion DM 1 in 1 CARTON SOLUTION 1 8 0031-8760-12 RobitussinChildrens Honey Day Night DM Value Pack 118 mL in 1 BOTTLE SOLUTION 1 mL 100 mg in 10mL 2 0031-8760-12 RobitussinChildrens Honey Day Night DM Value Pack 1 in 1 CARTON SOLUTION 100 mg in 10mL 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8760 CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [HALEON US HOLDINGS LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240427_b87f700e-3414-463c-80d4-c3dbca89a488.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0031-8760-12 00031876012 1 BOTTLE in 1 CARTON (0031-8760-12) / 118 mL in 1 BOTTLE 1 bottle 2018-06-25 0000-00-00 No No Current